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{{DrugProjectFormSinglePage
|authorTag={{AP}}
|genericName=Vigabatrin
|aOrAn=a
|drugClass=[[anticonvulsant]], [[gamma aminobutyric acid transaminase inhibitor]]
|indicationType=treatment
|indication=[[refractory complex partial seizures]] and [[infantile spams]]
|hasBlackBoxWarning=Yes
|adverseReactions=Weight increased (6% to 47% )
Musculoskeletal: Arthralgia (complex partial seizures, 10% )
Neurologic: Confusion (complex partial seizures, 4% ), Coordination problem (complex partial seizures, 7% ), Memory impairment (complex partial seizures, 7% ), Somnolence (6% to 45% ), Tremor (complex partial seizures, 6% to 15% )
Ophthalmic: Blurred vision (complex partial seizures, 13% ), Diplopia (complex partial seizures, 5% to 7% ), Nystagmus (complex partial seizures, 5% to 13% )
Otic: Infection of ear (infantile spasms, 7% to 14% ), Otitis media (complex partial seizures, 6%; infantile spasms, 10% to 44% )
Psychiatric: Aggressive behavior (complex partial seizures, 5% )
Reproductive: Dysmenorrhea (complex partial seizures, 9% )
Respiratory: Bronchitis (infantile spasms, 30% ), Upper respiratory infection (complex partial seizures, 7% to 10%; infantile spasms, 46% to 51% )
Other: Fatigue (9% to 28% )
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Vigabatrin in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Vigabatrin in adult patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Vigabatrin in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Vigabatrin in pediatric patients.
|alcohol=Alcohol-Vigabatrin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
}}
{{drugbox
{{drugbox
| IUPAC_name = 4-aminohex-5-enoic acid
| IUPAC_name = 4-aminohex-5-enoic acid

Revision as of 15:28, 23 January 2015

Vigabatrin
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

Disclaimer

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Black Box Warning

TITLE
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

Overview

Vigabatrin is a anticonvulsant, gamma aminobutyric acid transaminase inhibitor that is FDA approved for the treatment of refractory complex partial seizures and infantile spams. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Weight increased (6% to 47% ) Musculoskeletal: Arthralgia (complex partial seizures, 10% ) Neurologic: Confusion (complex partial seizures, 4% ), Coordination problem (complex partial seizures, 7% ), Memory impairment (complex partial seizures, 7% ), Somnolence (6% to 45% ), Tremor (complex partial seizures, 6% to 15% ) Ophthalmic: Blurred vision (complex partial seizures, 13% ), Diplopia (complex partial seizures, 5% to 7% ), Nystagmus (complex partial seizures, 5% to 13% ) Otic: Infection of ear (infantile spasms, 7% to 14% ), Otitis media (complex partial seizures, 6%; infantile spasms, 10% to 44% ) Psychiatric: Aggressive behavior (complex partial seizures, 5% ) Reproductive: Dysmenorrhea (complex partial seizures, 9% ) Respiratory: Bronchitis (infantile spasms, 30% ), Upper respiratory infection (complex partial seizures, 7% to 10%; infantile spasms, 46% to 51% ) Other: Fatigue (9% to 28% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Vigabatrin FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vigabatrin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Vigabatrin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Vigabatrin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Vigabatrin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Vigabatrin in pediatric patients.

Contraindications

There is limited information regarding Vigabatrin Contraindications in the drug label.

Warnings

TITLE
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

There is limited information regarding Vigabatrin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Vigabatrin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Vigabatrin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Vigabatrin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Vigabatrin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Vigabatrin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Vigabatrin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Vigabatrin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Vigabatrin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Vigabatrin in geriatric settings.

Gender

There is no FDA guidance on the use of Vigabatrin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Vigabatrin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Vigabatrin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Vigabatrin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Vigabatrin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Vigabatrin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Vigabatrin Administration in the drug label.

Monitoring

There is limited information regarding Vigabatrin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Vigabatrin and IV administrations.

Overdosage

There is limited information regarding Vigabatrin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Vigabatrin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Vigabatrin Mechanism of Action in the drug label.

Structure

There is limited information regarding Vigabatrin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Vigabatrin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Vigabatrin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Vigabatrin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Vigabatrin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Vigabatrin How Supplied in the drug label.

Storage

There is limited information regarding Vigabatrin Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Vigabatrin |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Vigabatrin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Vigabatrin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Vigabatrin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Vigabatrin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Vigabatrin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Vigabatrin
File:Vigabatrin.png
Clinical data
Routes of
administration		Oral
ATC code
Legal status
Legal status
  • Not a controlled substance
Pharmacokinetic data
Bioavailability80-90%
Protein binding0
MetabolismAlmost no metabolic transformation occurs
Elimination half-life5-8 hours in young adults, 12-13 hours in the elderly.
ExcretionRenal
Identifiers
CAS Number
PubChem CID
DrugBank
E number{{#property:P628}}
ECHA InfoCard{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
FormulaC6H11NO2
Molar mass129.157 g/mol

Vigabatrin is an anticonvulsant that inhibits the catabolism of GABA. It is an analog of GABA, but it is not a receptor agonist.[1]

Mechanism of action

Vigabatrin is an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the catabolism of GABA, which increases the level of GABA in the synapses.[1]

Vigabatrin is a racemic compound, and its [S]-enantiomer is pharmacologically active.[2],[3]

Pharmacokinetics

With most drugs, elimination half-life is a useful predictor of dosing schedules and the time needed to reach steady state concentrations. In the case of vigabatrin, however, it has been found that the half-life of biologic activity is far longer than the elimination half-life.[4]

For vigabatrin, there is no range of target concentrations because researchers found no difference between the serum concentration levels of responders and those of non-responders.[5] Instead, the duration of action is believed to be more a function of the GABA-T resynthesis rate; levels of GABA-T do not usually return to their normal state until six days after stopping the medication.[3]

Uses

Approved/clinically proven

Canada

In Canada, vigabatrin is approved for use as an adjunctive treatment (with other drugs) in treatment resistant epilepsy, complex partial seizures, secondary generalized seizures, and for monotherapy use in infantile spasms in West syndrome.[1]

Mexico

As of 2003, vigabatrin is approved in Mexico for the treatment of epilepsy that is not satisfactorily controlled by conventional therapy (adjunctive or monotherapy) or in recently diagnosed patients who have not tried other agents (monotherapy).[6]

Vigabatrin is also indicated for monotherapy use in secondarily generalized tonic-clonic seizures, partial seizures, and in infantile spasms due to West syndrome.[6]

Unapproved/Investigational

In November of 2001, a team of scientists lead by Peter Zwanzger of the University of Munich reported that vigabatrin reduced cholecystokinin tetrapeptide-induced symptoms of panic disorder, in addition to elevated cortisol and ACTH levels, in healthy volunteers.[7]

In 1994, Feucht and Brantner-Inthaler reported that vigabatrin reduced seizures by 50-100% in 85% of children with Lennox-Gastaut syndrome who had poor results with a valproate.[8]

In 1984, a double-blind crossover-study of six Huntington's disease patients—five of them on antipsychotics—reported that vigabatrin did little, if anything, to improve hyperkinetic movements, the ability to carry out daily activities, or normalize motor function.[9]

Adverse effects

Central nervous system

Common

Out of 2,081 subjects, somnolence (12.5%), headache (3.8%), dizziness (3.8%), nervousness (2.7%), depression (2.5%), memory disturbances (2.3%), diplopia (2.2%), aggression (2.0%), ataxia (1.9%), vertigo (1.9%), hyperactivity (1.8%), vision abnormalities (1.6%), confusion (1.4%), insomnia (1.3%), impaired concentration (1.2%), personality disorder (1.1%).[1] Out of 299 children, 33 (11%) became hyperactive.[1]

Rare

Some patients develop psychosis during the course of vigabatrin therapy,[10] which is more common in adults than in children.[11] This can happen even in patients with no prior history of psychosis.[12] Other rare CNS side effects include anxiety, emotional lability, irritability, tremor, abnormal gait, and speech disorder.[1]

Gastrointestinal

Common

Abdominal pain (1.6%), constipation (1.4%), vomiting (1.4%), and nausea (1.4%).[1]

Rare

Dyspepsia and increased appetite occurred in less than 1% of subjects in clinical trials.[1]

Body as a Whole

Common

Fatigue (9.2%), weight gain (5.0%), asthenia (1.1%).[1]

Teratogenicity

A teratology study conducted in rabbits found that a dose of 150mg/kg/day caused cleft palate in 2% of pups and a dose of 200 mg/kg/day caused it in 9%.[1] This may be due to a decrease in methionine levels, according to a study published in March of 2001.[13] In 2005, a study conducted at the University of Catania was published stating that rats whose mothers had consumed 250-1000 mg/kg/day had poorer performance in the water maze and open-field tasks, rats in the 750-mg group were underweight at birth and did not catch up to the control group, and rats in the 1000 mg group did not survive pregnancy.[14]

There is no controlled teratology data in humans to date.

More on "abnormal vision"

In 2003, vigabatrin was shown by Frisén and Malmgren to cause irreversible diffuse atrophy of the retinal nerve fiber layer in a retrospective study of 25 patients.[15] This has the most effect on the outer area (as opposed to the macular, or central area) of the retina.[16]

Drug interactions

A study published in 2002 found that vigabatrin causes a statistically significant increase in plasma clearance of carbamazepine.[17]

In 1984, Drs Rimmer and Richens at the University of Wales reported that administering vigabatrin with phenytoin lowered the serum phenytoin concentration in patients with treatment-resistant epilepsy.[18] The concentration of phenytoin falls to 23% within five weeks, according to an experiment published in 1989 by the same two scientists that tried and failed to elucidate the mechanism behind this interaction.[19]

Brand names

Vigabatrin is sold as Sabril® in Canada,[20] Mexico,[6] and the United Kingdom.[21] The brand name in Denmark is Sabrilex®.

References and end notes

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 Long, Phillip W. "Vigabatrin." Internet Mental Health. 1995-2003.
  2. ↑ Sheean, G. (1992). "Vigabatrin--plasma enantiomer concentrations and clinical effects". Clinical and Experimental Neurology. 29: 107–16. PMID 1343855. Unknown parameter |coauthors= ignored (help)
  3. ↑ 3.0 3.1 Gram L, Larsson OM, Johnsen A, Schousboe A (1989). "Experimental studies of the influence of vigabatrin on the GABA system". British Journal of Clinical Pharmacology. 27 (Suppl 1): 13S–17S. PMID 2757904.
  4. ↑ Browne TR (1998). "Pharmacokinetics of antiepileptic drugs". Neurology. 51 (5 suppl 4): S2–7. PMID 9818917.
  5. ↑ Lindberger M, Luhr O, Johannessen SI, Larsson S, Tomson T (2003). "Serum concentrations and effects of gabapentin and vigabatrin: observations from a dose titration study". Therapeutic Drug Monitoring. 25 (4): 457–62. PMID 12883229.
  6. ↑ 6.0 6.1 6.2 DEF MEXICO: SABRIL Diccionario de Especialdades Farmaceuticas. Edicion 49, 2003.
  7. ↑ Zwanzger P, Baghai TC, Schuele C, Strohle A, Padberg F, Kathmann N, Schwarz M, Moller HJ, Rupprecht R (2001). "Vigabatrin decreases cholecystokinin-tetrapeptide (CCK-4) induced panic in healthy volunteers". Neuropsychopharmacology. 25 (5): 699–703. PMID 11682253.
  8. ↑ Feucht M, Brantner-Inthaler S (1994). "Gamma-vinyl-GABA (vigabatrin) in the therapy of Lennox-Gastaut syndrome: an open study" (PDF). Epilepsia. 35 (5): 993–8. PMID 7925171. Retrieved 2006-05-25.
  9. ↑ Scigliano G, Giovannini P, Girotti F, Grassi MP, Caraceni T, Schechter PJ (1984). "Gamma-vinyl GABA treatment of Huntington's disease". Neurology. 34 (1): 94–6. PMID 6228746.
  10. ↑ Sander JW, Hart YM (1990). "Vigabatrin and behaviour disturbance". Lancet. 335 (8680): 57. PMID 1967367.
  11. ↑ Chiaretti A, Castorina M, Tortorolo L, Piastra M, Polidori G (1994). "[Acute psychosis and vigabatrin in childhood]". La Pediatria Medica e Chirurgica : Medical and surgical pediatrics. 16 (5): 489–90. [Article in Italian] PMID 7885961
  12. ↑ Sander JW, Hart YM, Trimble MR, Shorvon SD (1991). "Vigabatrin and psychosis". Journal of Neurology, Neurosurgery, and Psychiatry. 54 (5): 435–9. PMID 1865207.
  13. ↑ Abdulrazzaq YM, Padmanabhan R, Bastaki SM, Ibrahim A, Bener A (2001). "Placental transfer of vigabatrin (gamma-vinyl GABA) and its effect on concentration of amino acids in the embryo of TO mice". Teratology. 63 (3): 127–33. PMID 11283969.
  14. ↑ Lombardo SA, Leanza G, Meli C, Lombardo ME, Mazzone L, Vincenti I, Cioni M (2005). "Maternal exposure to the antiepileptic drug vigabatrin affects postnatal development in the rat". Neurological Sciences. 26 (2): 89–94. PMID 15995825.
  15. ↑ Frisén L, Malmgren K (2003). "Characterization of vigabatrin-associated optic atrophy". Acta Ophthalmologica Scandinavica. 81 (5): 466–73. PMID 14510793.
  16. ↑ Buncic JR, Westall CA, Panton CM, Munn JR, MacKeen LD, Logan WJ (2004). "Characteristic retinal atrophy with secondary "inverse" optic atrophy identifies vigabatrin toxicity in children". Ophthalmology. 111 (10): 1935–42. PMID 15465561.
  17. ↑ Sanchez-Alcaraz, Agustín (2002). "Effect of vigabatrin on the pharmacokinetics of carbamazepine". Journal of Clinical Pharmacology and Therapeutics. 27 (6): 427–30. PMID 12472982. Unknown parameter |coauthors= ignored (help)
  18. ↑ Rimmer EM, Richens A (1984). "Double-blind study of gamma-vinyl GABA in patients with refractory epilepsy". Lancet. 1 (8370): 189–90. PMID 6141335.
  19. ↑ Rimmer EM, Richens A (1989). "Interaction between vigabatrin and phenytoin". British Journal of Clinical Pharmacology. 27 (Suppl 1): 27S–33S. PMID 2757906.
  20. ↑ drugs.com Vigabatrin Drug Information
  21. ↑ Treatments for Epilepsy - Vigabatrin Norfolk and Waveney Mental Health Partnership NHS Trust

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